Small particle steroid study

ISRCTN	ISRCTN17195095
DOI	https://doi.org/10.1186/ISRCTN17195095
Secondary identifying numbers	N/A

Submission date: 21/12/2012
Registration date: 07/01/2013
Last edited: 28/07/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
The small airways (that carry air in and out of the lungs) have become increasingly important in asthma. We now have non-invasive tests of small airways function at our disposition, as well as inhaled drugs (containing smaller aerosol particles) targeting asthma at the level of the small airways. The aim of this study was to assess whether inhaled medications targeting the small airways offer any benefit over regular asthma drugs in terms of lung function (and more specifically small airways function) and asthma control. In addition the study will provide useful information about the inflammatory and structural alterations in the small airways.

Who can participate?
Non-smoking asthma patients, both male and female, over 18 years old on inhaled corticosteroids ("controller" drugs for asthma) and with abnormalities in the small airways can participate. Pregnant women were excluded from the study.

What does the study involve?
The study involved two patient groups: during a 15 week period the first group was treated with inhaled asthma medications targeting the small airways, whereas patients in the second group remained on regular asthma drugs. Lung function tests were performed before starting and after 3, 9 and 15 weeks. At each of those time point patients were also asked to fill out a short questionnaire (5 minutes) about their asthma. Each of the four study visits took approximately 1 hour. The asthma treatment was not interrupted throughout the entire study.

What are the possible benefits and risks of participating?
Study medication will be provided without any cost. No additional side effects are expected from the study medication, other than those related to the regular asthma treatment patients are already on. There are no risks associated with the lung function testing.

Where is the study run from?
The study took place in the UZ Brussel's (university hospital) outpatient clinic.

When is the study starting and how long is it expected to run for?
The study started in September 2009 and ran until August 2012.

Who is funding the study?
This study was funded by UCB Pharma.

Who is the main contact?
Dr Shane Hanon
shane.hanon@uzbrussel.be

Contact information

Dr Shane Hanon
Scientific

Laarbeeklaan 101
Brussels
1090
Belgium

Email	shane.hanon@uzbrussel.be

Study information

Study design	Randomized double-blind double-dummy study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet [available in Dutch and French]
Scientific title	Small particle steroid study: a randomized double blind double dummy study
Study objectives	The residual lung function abnormalities in the small airways of the conductive and acinar lung zone could be smaller with the ultrafine anti-inflammatory aerosol [beclomethasone dipropionate (HFA-BDP); QVAR)] than with a regular anti-inflammatory aerosol [budesonide (DPI-BUD); Pulmicort TH)] in asthma patients with pre-existing small airways dysfunction.
Ethics approval(s)	Medical Ethics Committee of UZ Brussel, 02/04/2009, ref: 2009/043, B.U.N. B14320096121
Health condition(s) or problem(s) studied	Asthma / Small airways
Intervention	After a 3-week run-in on DPI-BUD patients are randomized to either arm 1 (DPI- BUD switched to BDP-HFA from wk 4 to wk 15) or to arm 2 (remaining on DPI-BUD) The intervention takes 15 weeks.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Qvar (beclomethasone dipropionate), Pulmicort (Budesonide)
Primary outcome measure	Change in Sacin (Multiple Breath Nitrogen Washout test). Sacin is a measure of ventilation heterogeneity in the acinar lung zone. Sacin increases with increasing heterogeneity. Measured at baseline and after 3, 9 and 15 weeks.
Secondary outcome measures	1. Alveolar and bronchial exhaled NO 2. Lung function parameters 3. Asthma control test (ACT) score Measured at baseline and after 3, 9 and 15 weeks.
Overall study start date	01/09/2009
Completion date	31/08/2012

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	35
Key inclusion criteria	1. Well-established, stable asthma patients on inhaled corticosteroids 2. Age >18 years, male/female 3. Elevated baseline Sacin (>0.12 L-1)
Key exclusion criteria	1. Smoking history (> 10 packyears) or current smokers 2. Pregnant women
Date of first enrolment	01/09/2009
Date of final enrolment	31/08/2012

Locations

Countries of recruitment

Belgium

Study participating centre

Laarbeeklaan 101

Brussels
1090
Belgium

Sponsor information

University Hospital Brussels (Universitair Ziekenhuis Brussel [UZ Brussel]) (Belgium)
Hospital/treatment centre

Laarbeeklaan 101
Brussels
1090
Belgium

Website	http://www.uzbrussel.be
"ROR"	https://ror.org/038f7y939

Funders

Funder type

Industry

UCB Pharma Brussels (Belgium) - Research grant

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/11/2014		Yes	No